Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 10:19 AM
Study NCT ID:
NCT06295835
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood
Sponsor:
Organization:
Raw JSON
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This objective will be assessed as part of a Method Comparison evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated consent form (if required by the IRB)\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n• Prior enrollment in the study'}, 'identificationModule': {'nctId': 'NCT06295835', 'briefTitle': 'Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Point of Care'}, 'officialTitle': 'Clinical Evaluation of the Potassium (K) and Ionized Calcium (iCa) Tests in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer', 'orgStudyIdInfo': {'id': 'CS-2024-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Method comparison for K and iCa Tests using capillary whole blood specimens.', 'description': 'Compare the performance of the K and iCa Tests using the IUO i-STAT CG8+ Cartridge on the i-STAT 1 Analyzer to the performance of the K and iCa Tests on the comparator device using capillary whole blood specimens collected from two separate fingersticks.', 'interventionNames': ['Diagnostic Test: Fingerstick blood draw']}], 'interventions': [{'name': 'Fingerstick blood draw', 'type': 'DIAGNOSTIC_TEST', 'description': 'Capillary blood specimen collected from two separate fingersticks.', 'armGroupLabels': ['Method comparison for K and iCa Tests using capillary whole blood specimens.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland (UMD)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University Hershey Medical Center (Hershey)', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '98052', 'city': 'Redmond', 'state': 'Washington', 'country': 'United States', 'facility': 'Eastside Research Associates (ERA)', 'geoPoint': {'lat': 47.67399, 'lon': -122.12151}}, {'zip': 'K2H 8V4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Abbott Point of Care (APOC)', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Manish Gupta, BS, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Point of Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Point of Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}